# FDA 483 - Medtronic Neuromodulation - January 21, 2011

Source: https://www.keypedia.com/records/483/medtronic-neuromodulation/f21b8cb5-3478-4780-aec4-4e5833994a7e

> FDA 483 for Medtronic Neuromodulation on January 21, 2011. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Neuromodulation
- Inspection Date: 2011-01-21
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Medtronic Neuromodulation in Minneapolis, MN, revealed significant deficiencies in quality system processes. The firm failed to adequately validate manufacturing processes and product designs, and exhibited severe issues with complaint handling and corrective and preventive action documentation. These observations indicate a systemic breakdown in ensuring product quality and safety.

## Related Officers

- [Susan M. Atcher](https://www.keypedia.com/people/susan-m-atcher/445bf2f8-3a11-4e9b-8663-87a42b2e8757)
- [Jessica L. Johnson](https://www.keypedia.com/people/jessica-l-johnson/9ea42c42-c28b-4945-a862-6b77617177f9)

Company: https://www.keypedia.com/companies/medtronic-neuromodulation/8379de30-31d7-45f5-a6e2-7f541f95e6f5

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d